Circular surgical staplers with isolating sleeves stored inside anvil

Abstract

The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to enhance the properties of repaired or adjoined tissue at a target surgical site, especially when sealing an anastomosis between adjacent intestinal sections so as to improve tissue viability, prevent tissue infection, and to prevent leakage. The present invention further relates to circular stapling instruments and elongated tubular hollow sleeves deployed from such stapling instruments and establishing an enclosure around the stapled and resected tissues at the anastomotic joint.

We claim: 
     
       1. A circular stapling instrument comprising:
 a) an anvil having a tissue facing end and an opposite distal end;
 the anvil having a peripheral staple bending zone and a coaxial circular knife recess on said tissue facing end; 
 the anvil having a circumferential recess formed inside said anvil, with a circumferential entrance into said circumferential recess positioned on said tissue facing end coaxially between the staple bending zone and the circular knife recess; 
 
 b) a cylindrical stapling head mounted on a support shaft, said stapling head containing a concentric knife and a plurality of deployable staples in concentric arrays on a tissue facing side of said stapling head; 
 c) a moveable shaft connecting the anvil and stapling head; and 
 d) an elongated hollow anvil sleeve having a flange at a proximal end thereof,
 said anvil sleeve open at a distal end thereof and at the proximal end thereof; 
 said flange positioned on the tissue facing end of the anvil against said staple bending zone; wherein said distal end of said anvil sleeve is releasably disposed in said circumferential recess, 
 said distal end of said anvil sleeve configured to be turned outside-in and inverted upon release from said circumferential recess after stapling, 
 wherein said anvil sleeve, said circumferential recess, and said circumferential entrance are configured to avoid any interference and any contact of the anvil sleeve with the concentric knife moving against and within circular knife recess. 
 
 
     
     
       2. The circular stapling instrument of  claim 1 , wherein the circumferential entrance is configured not to overlap with the staple bending zone. 
     
     
       3. The circular stapling instrument of  claim 1 , wherein the circumferential entrance is configured not to overlap with the circular knife recess. 
     
     
       4. The circular stapling instrument of  claim 1 , wherein a circular separation wall is formed on said tissue facing end of said anvil coaxially between the circumferential entrance and the circular knife recess. 
     
     
       5. The circular stapling instrument of  claim 1 , wherein said anvil sleeve is tubular or frustoconical. 
     
     
       6. The circular stapling instrument of  claim 1 , wherein said anvil sleeve, said circumferential recess, and said circumferential entrance are configured to avoid any interference and any contact of the anvil sleeve with the concentric knife before, during, and after stapling with said circular stapling instrument. 
     
     
       7. The circular stapling instrument of  claim 1 , wherein said anvil sleeve further comprises an inner flange extending the flange towards center of said anvil sleeve. 
     
     
       8. The circular stapling instrument of  claim 7 , wherein said inner flange is cut by said concentric knife during stapling with said circular stapling instrument. 
     
     
       9. The circular stapling instrument of  claim 1 , wherein a portion of the anvil sleeve intermediate between the flange and the distal end of said anvil sleeve passes through the circumferential entrance. 
     
     
       10. The circular stapling instrument of  claim 1 , wherein said anvil sleeve is folded on itself or rolled on itself or inverted or turned outside-in or turned inside-out at said distal end of said anvil sleeve. 
     
     
       11. The circular stapling instrument of  claim 1 , wherein said anvil sleeve further comprises a buttress disposed on the flange. 
     
     
       12. The circular stapling instrument of  claim 1 , wherein said anvil sleeve has multiple perforations. 
     
     
       13. The circular stapling instrument of  claim 1 , wherein said anvil sleeve has multiple perforations in the distal end thereof. 
     
     
       14. The circular stapling instrument of  claim 1 , wherein at least a portion of said anvil sleeve is erodible, dissolvable, or resorbable in a mammalian gastrointestinal tract over a period ranging from 1 to 8 weeks. 
     
     
       15. The circular stapling instrument of  claim 1 , wherein said anvil sleeve is at least partially coated or impregnated with a releasable anti-bacterial, anti-microbial, anti-infective agent, bacterial culture, or combinations thereof. 
     
     
       16. The circular stapling instrument of  claim 1 , wherein at least a portion of said anvil sleeve has varying mechanical properties along the sleeve. 
     
     
       17. The circular stapling instrument of  claim 1 , wherein the flange is thicker and less flexible than the rest of said sleeve. 
     
     
       18. The circular stapling instrument of  claim 1 , wherein an expandable elastic ring is incorporated into said distal end of said anvil sleeve. 
     
     
       19. A method of establishing an anastomotic joint between tubular tissue lumens with the circular stapling instrument of  claim 1 , the method comprising the steps of:
 a. axially positioning the anvil sleeve on the anvil; axially inserting said anvil into a first tubular tissue and closing said first tubular tissue around said anvil; 
 b. axially inserting said stapling head into a second tubular tissue; 
 c. connecting said anvil to said stapling head via the moveable shaft; 
 d. approximating said anvil and said stapling head to compress said first and second tubular tissues between said stapling head and said anvil; 
 e. firing said anastomotic stapler to form a stapled anastomotic joint between said first and second tubular tissues and simultaneously stapling said anvil sleeve to said first and second tubular tissue; 
 f. withdrawing said anastomotic stapler from said first and second tubular tissues, leaving said anvil sleeve inside said first and second tubular tissues, 
 g. turning and inverting said anvil sleeve outside-in; 
 h. extending said anvil sleeve from said first tubular tissue into said second tubular tissue; and 
 i. leaving said anvil sleeve inside said first and second tubular tissues for sufficient time for at least partial healing of said tissues at the anastomotic joint.